May 7, 2014 - Notice of Clarification of Application Submission Instructions for PAR-12-156. See Notice NOT-AI-14-056.

November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.

The purpose of the NIAID Research Scholar Development
Award (CTA) program is to increase and maintain a strong cohort of new and
talented NIH-supported independent investigators that will address the health
needs of the Nation. The NIAID CTA is specifically designed to facilitate
the transition from a postdoctoral research position to an independent
research position.

Key Dates

Posted Date

April 10, 2012

Open Date (Earliest Submission Date)

May 12, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard
dates apply , by 5:00 PM local time of applicant organization.

The objective of the of the NIAID CTA is to support
postdoctoral fellows transitioning to positions of assistant professor or
equivalent, and initiate a successful biomedical career as an independent research
scientist.

NIH believes that the creativity and innovation of new
independent investigators in their early career stages play an integral role in
addressing our Nation’s biomedical, behavioral, and clinical research needs.
However, the average age of first-time (new) Principal Investigators obtaining
R01 research funding from the NIH has risen to 42 years for Ph.D. degree
holders and 44 years for M.D./Ph.D. degree holders. The intent of the NIAID K22
program is to help alleviate this trend and to assist new investigators in
transitioning to stable independent research positions at an earlier age and
with an enhanced probability of success in obtaining independent NIH or other
independent research support.

Nature
of the career/research transition opportunity

The K22 award will provide two years of support to conduct biomedical
research as an independent scientist at an extramural sponsoring
institution/organization to which the individual has been recruited, been
offered and has accepted a tenure-track full-time assistant professor position
(or equivalent). This support is to allow the individual to continue to work
toward establishing his/her own independent research program and prepare an
application for regular research grant support (R01).

The postdoctoral fellow, also referred to as a candidate,
submits a K22 application from the institution where s/he currently pursues
his/her postdoctoral research training. The application will be peer
reviewed and assigned an overall impact score. Successful candidates
(i.e. whose application has received a fundable overall impact score) will
receive an approval letter from NIAID that will include the terms and
conditions to activate the K22 award. In order to activate the K22 award, the
candidate will need to secure a tenure-track full-time assistant professor
position within a year of the receipt of the approval letter. Once the
assistant professor position has been secured, the candidate will submit
updated information about the K22 application with the support of the
sponsoring institution. The sponsoring institution can be the same as the
post-doctoral institution, though it is most likely a different institution
from the original submission of the K22 application. The updated
information of the transition to an assistant professor position at the
sponsoring institution will be evaluated by senior NIAID staff to ensure that
all programmatic requirements are met prior to the activation of the K22 award. The details of the requirements for the
activation of the K22 award are described in Section VI of this announcement.

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

Award budgets are composed of salary and other
program-related expenses, as described below.

Award Project Period

The total project period may not exceed 2 years. .

Other Award Budget Information

Salary

NIH will contribute no more than $50,000 plus fringe benefits per year toward the salary of the career award
recipient.

The total salary requested must be based on a full-time staff appointment. The
salary must be consistent both with the established salary structure at the
institution and with salaries actually provided by the institution from its
own funds to other staff members of equivalent qualifications, rank, and
responsibilities in the department concerned.

The sponsoring institution may supplement the NIH salary contribution up to a
level that is consistent with the institution's salary scale. However,
supplementation may not be from Federal funds unless specifically authorized
by the Federal program from which such funds are derived. In no case may PHS
funds be used for salary supplementation. Institutional supplementation of
salary must not require extra duties or responsibilities that would interfere
with the purpose of the career award.

Other Program-Related Expenses

In the first year of the K22 award, NIAID will contribute
up to $150,000 (total direct cost), and in the second year up to $100,000
(total direct cost) toward the research development costs of the award
recipient, which must be justified and consistent with the stage of
development of the candidate and the proportion of time to be spent in
research or career development activities. The PI will have discretion to
utilize the award as needed by the research described in the application.
However, no more than $50,000 per year of the award may be utilized to
support the Principal Investigator’s salary.

Salary for mentors, secretarial and administrative
assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs.

NIH grant policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

NIH intramural laboratories and other eligible agencies of
the Federal Government are eligible to submit a K22 application on behalf of
intramural candidates. In order for an intramural postdoctoral fellow to
activate the K22 award, the candidate must transition to an assistant professor
position at an extramural institution.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support. Multiple Principal Investigators are not
allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have earned a terminal
clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS,
PharmD, or equivalent doctoral degree), or a combined clinical and research
doctoral degree.

Individuals affiliated with an NIH Intramural Laboratory may
apply (specific
information is available for intramural candidates on the Electronic
Submission Intranet – link available only to users internal to NIH).

Individuals not affiliated with an organization may apply (specific information is available for unaffiliated candidates).

Individuals are NOT eligible if they:

Have currently or previously held an independent research faculty
or tenure-track faculty position, or its equivalent, in academia, industry or
elsewhere; or

Have more than 5 years of related postdoctoral research experience
at the time of the relevant standard receipt date for the initial application
or resubmission; or

Have been an independent principal investigator on NIH research
grants (e.g. R01 or equivalent), NIH career development awards (e.g., K01, K07,
K08, K23, K25), or other peer reviewed NIH or non-NIH research grants over
$100,000 direct costs per year, or project leaders on sub-projects of multi-project
applications (e.g. P01, U19).

Some institutions
appoint postdoctoral fellows in positions with other titles although they are
still in non-independent training positions. Candidates in such positions are encouraged to obtain
confirmation of their eligibility before they begin to prepare their
applications. It is incumbent upon the candidate to provide
evidence that the position s/he is in complies with the intent of this
eligibility requirement. Evidence for non-independence may include:

The candidate’s research is entirely funded by another
investigator’s grants.

The candidate’s research is conducted entirely in another
investigator’s assigned space.

According to institutional policy, the candidate cannot hire
postdoctoral fellows or be the responsible supervisor of graduate students.

The candidate lacks other rights and privileges of faculty, such
as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack of eligibility,
includes:

The candidate has a full-time tenure track assistant professor
position (or equivalent).

The candidate received a startup package for support of his/her
independent research.

Clinicians (including
those with MD, DDS, DVM and other licensed professionals) in positions not
designated as postdoctoral positions:

Following clinical training or fellowship training periods,
clinicians often obtain a clinical faculty position that denotes independence
in clinical responsibilities but not in research. A clinical faculty member who
does not hold an independent research faculty position may be eligible for the K22
award and should contact the NIAID Scientific/Research (see below) for
guidance. Clinicians in such positions are encouraged to obtain confirmation of
their eligibility before they begin to prepare their applications. Such
individuals may also wish to consider other career awards (e.g., K08, K23) available
for junior faculty development.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed. An individual may not have two or more competing
NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Individuals are eligible for a K22 award if they have been,
or currently are, the PI of an NIH R03 or R21 grant or a PHS or non-Federal
award that duplicates the provisions or research goals of an R03 or R21 grant. Individuals
are NOT eligible to apply if they have pending an application for any other PHS
career development award, an NIH institute-specific K22, or a Pathway to
Independence Award (K99/R00). Individuals are not eligible to apply if they have
been or are currently a PI on an NIH research grant (such as R01) or a
subproject leader on a Program Project (P01) or Center Grant (P50), or a
non-NIH equivalent to these grants/awards.

Level of Effort

At the time of award, the candidate must have a “full-time”
appointment at the academic institution that is the applicant institution. Candidates
who have VA appointments may not consider part of the VA effort toward
satisfying the “full time” requirement at the applicant institution. Candidates
with VA appointments should contact the staff person in the relevant Institute
or Center prior to preparing an application to discuss their eligibility. Under
certain circumstances, an awardee may submit a written request to the awarding component
requesting a reduction in minimum required percent effort, which will be
considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Section IV. Application and Submission
Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow the instructions in the SF 424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Candidate’s Background (Component of Candidate
Information)

Describe prior training and research efforts, and how they relate
to the objectives and long-term career plans of the candidate.

Provide evidence of the candidate's potential to develop into a
successful independent investigator. Usually this is evident from publications,
prior research interests and experience, and letters of reference.

Describe a systematic plan that shows a logical progression from the
candidate's prior research and training experiences to the research and career
development experiences of the current position and subsequently then to
independent investigator status.

Describe the candidate’s current as well as long-term research
and career objectives

Career Development/Training Activities During Award
Period (Component of Candidate Information)

The candidate is responsible for the preparation of the career
development plan and consultation with the current postdoctoral advisor is
highly encouraged. A timeline including publications is strongly encouraged.

The career development plan must be tailored to the needs of the
individual candidate and the ultimate goal of achieving independence as a
researcher. This plan should describe activities such as those that will lead
to new and/or enhanced research, grant-writing, communication and laboratory
management skills and knowledge.

The candidate should describe how the career development plan
will promote the candidate's success and scientific independence.

The candidate must describe the plan of his/her transition to the
independent investigator status.

Training in the Responsible Conduct of Research
(Component of Candidate Information)

Individuals are required to comply with the instructions for
Training in the Responsible Conduct of Research as provided in Chapter 7 of the
SF424 (R&R) Application Guide

Statements by Consultants, Contributors (Component of
Statements of Support)

Signed statements must be provided by each collaborator/consultant
confirming their participation in the project and describing their specific
roles. Information should be provided that clearly documents expertise in the
proposed area(s) of collaboration/consultation. Any other opportunities for the
candidate’s professional growth should also be documented in these statements.

Since this is not a mentored award, a statement by the current
postdoctoral advisor should not be included unless s/he will serve as a
consultant or contributor during the K22 award.

Description of Institutional Environment (Component of
Environment and Institutional Commitment to the Candidate)

Due to the nature of this award, the candidate may not have
identified a sponsoring institution at the time of submitting the K22
application. Describe how the current institutional research environment is supportive
in the development of the candidate's research career and transition to an
independent investigator.

Institutional Commitment to the Candidate’s Research
Career Development (Component of Environment and Institutional Commitment to
the Candidate)

For activation of the K22 award the sponsoring institution must
provide a statement of commitment to the candidate’s development into a
productive, independent investigator and to meeting the requirements of the
award. The sponsoring institution must provide the candidate with the
appropriate facilities and other resources to carry out the proposed Research
Plan.

Research Strategy (Component of Research Plan)

A sound research project that is consistent with the candidate’s
level of research development and objectives of his/her career development plan
must be provided. The research description should demonstrate not only the
quality of the candidate’s research thus far but also the novelty,
significance, creativity and approach, as well as the ability of the candidate
to carry out the proposed research.

The application must also describe the relationship between the current
postdoctoral advisor's research and the candidate’s proposed research plan. The
application should describe how the candidate will gain independence from
his/her current mentor(s) and achieve separation of his/her scientific research
program from that of the postdoctoral advisor (s).

The candidate should include a description of the research
conducted during the candidate’s tenure as a postdoc and a detailed description
of the research planned during the K22 award. This narrative
should also describe what the candidate will accomplish during the K22 award
period that will enable her/him to compete successfully for independent research
support beyond the K22.

For the NIAID K22
application complete ALL sections the SF 424 Research and Related (R&R)
Forms with the following modifications:

For period of support, indicate the total period of support being
requested: 2 years.

For the project summary, briefly describe the research you
propose during the two year K22 award period.

Follow the budget format instructions as described in Section III
of the PHS 398 application.

The maximum direct cost budget is $150,000 in year 1 and $100,000
in year 2. No detailed budget information is required at the time of
application for Phase 1.

A Budget Justification does not need to be provided at the time
of submission of the K22 application.

Appendix

Do not use the Appendix to circumvent page limits.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Letters of Reference

Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when letters of reference
will be accepted (letters are due by the application due date as described
in the Notice).
Applications lacking the appropriate required reference letters will not be
reviewed. This is a separate process from submitting an application
electronically. Reference letters are submitted directly through the eRA Commons
Submit Referee Information link and not through Grants.gov.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants are
responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of on-time submission are
provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for
more information on the electronic submission process, visit Applying
Electronically.

Important reminders:All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

The objective of the of the NIAID CTA is to support postdoctoral fellows
transitioning to positions of assistant professor or equivalent, and initiate a
successful biomedical career as an independent research scientist. The K22
award will provide two years of support to conduct research as an independent
scientist at an extramural sponsoring institution/organization to which the
individual has been recruited, been offered and has accepted a tenure-track
full-time assistant professor position (or equivalent). This support is to
allow the individual to continue to work toward establishing his/her own
independent research program and prepare an application for regular research
grant support (R01).

Overall Impact

Reviewers should provide their assessment of the likelihood
for the candidate to maintain a strong research program, taking into
consideration the criteria below in determining the overall impact/priority
score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Candidate

Does the candidate have the potential for becoming a
successful independent investigator who will contribute significantly to a
chosen health-related research field? Will the prior research experiences prepare
the candidate to transition successfully to an independent research scientist? Do
the letters of reference from at least three well-established scientists
address the candidate’s potential for becoming an independent investigator?

Career Development Plan/ Career Goals & Objectives/
Plan to Provide Mentoring

What is the likelihood that the plan will contribute
substantially to the scientific development of the candidate leading to
scientific independence? Are the candidate's prior training and research experience
appropriate for this award? Are the content, scope, phasing, and duration of
the career development plan appropriate when considered in the context of prior
training/research experience and the stated training and research objectives
for achieving research independence?

Research Plan

Is the proposed research project appropriate for the
candidate’s stage of research development and as a vehicle for development of the
research skills described in the career development plan? Are the scientific and
technical merits of the research question, design, and methodology appropriate
in the context of prior training and experience? Is the proposed research
relevant to stated career objectives?

Consultant(s), Collaborator(s)

Is adequate information provided that clearly
documents expertise in the proposed area(s) of consulting/collaboration? Have
the proposed consultant(s) and collaborator(s) provided evidence of commitment
to the candidate and the candidate’s project? Do the proposed consultant(s)/collaborator(s)
provide the required expertise for successful conduct of the research project?

Environment & Institutional Commitment to the Candidate

What evidence is provided that the candidate's
current institution is strongly committed to fostering the candidate’s
development and transition to become an independent investigator?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: (1) the justification for the exemption, (2) human
subjects involvement and characteristics, and (3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: (1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; (2) justifications for the use of animals
and for the appropriateness of the species and numbers proposed; (3) adequacy
of veterinary care; (4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and (5) methods of euthanasia and
reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the
candidate, including level of experience, the reviewers will address the
following questions. Does the plan satisfactorily address the format of
instruction, e.g., lectures, coursework, and/or real-time discussion groups?
Do plans include a sufficiently broad selection of subject matter, such as
conflict of interest, authorship, data management, human subjects and animal
use, laboratory safety? Do the plans adequately describe the role of the
sponsor/mentor or other faculty involvement in the candidate’s instruction?
Does the plan meet the minimum requirements for RCR, i.e., eight contact hours
of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of
the review committee.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s),convened by the NIAID in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned to NIAID. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of
review by the National Advisory Allergy and Infectious Diseases Councill. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

There will not be a formal Notice of Award (NoA) associated after
peer review of K22 applications. NIAID will transmit to the successful candidate
an approval letter that will include the terms and conditions of the activation
of the NIAID K22 award, as well as expectations for the transition to the independent
investigator position.

If the candidate receives a fundable overall impact score after
the review of the K22 application, s/he will be notified in writing of NIAID's
commitment to make an award. The candidate will then have a period of up to 12
months to identify a suitable position as an assistant professor or equivalent
at a domestic academic institution and negotiate an acceptable start-up
package. As soon as negotiations between the candidate and the institution are
complete, the updated information about the K22 application must be submitted.

The sponsoring institution will submit the updated information on behalf of the
candidate for the K22 award using the PHS398
Application.

The updated information about the K22 application must include:

A new face page signed by the sponsoring institutional
representative;

Detailed budget pages for a non-modular budget;

Budget Justification

A new Resources page;

An updated career development plan

A new checklist.

In addition, a letter from the sponsoring Department or
Division Chair describing the sponsoring institution’s commitment to the
candidate and plans for his/her career development should be submitted (i.e.
percent effort, laboratory space , start-up funding; see also below).

These materials should be sent directly to NIAID. The
original application plus one copy (preferably in a PDF format) are to be
mailed to the NIAID Financial or Grants Management contact person (see below). The
updated information about the K22 application will be evaluated by extramural
program staff of NIAID for completeness and responsiveness to the program.

An institutional commitment agreement will be required at the time of
activation of the K22 award. This agreement should satisfy the criteria described
in the Career Development Award Section of the SF424 (R&R) Application
Guide.

In addition to space, facilities, resources, and other support needed to
conduct the proposed research, the sponsoring institution must provide
protected research time (minimum of 9 person-months [75% full time professional
effort]) at least for the duration of the K22 award. The start-up package and
other institutional support must be described and should be comparable to that
given to other faculty recently hired into tenure-track or equivalent positions.
Institutions must provide a startup and salary package equivalent to that
provided to a newly hired faculty member who does not have a grant; K22 funds
may not be used to offset the typical startup package or to offset the usual
institutional commitment to provide salary for tenure-track (or equivalent)
assistant professors who are hired without grant support. The K22 sponsoring
institution should describe the candidate’s academic appointment, bearing in
mind that it must be tenure-track assistant professor (or equivalent). The sponsoring
institution must foster and support the awardee’s ability to apply for and
secure independent research grant (R01) support.

The K22 award requires that a minimum of 9 person-months (75% full time
professional effort) be devoted to research activities. Consequently, teaching,
clinical duties and other non-research activities should be minimal during the K22
award period. NIH staff may review start-up packages and other commitments
between the institution and candidate prior to activating of the K22 award. It
is suggested that the applicant and/or the hiring institution discuss the
institutional commitment with the relevant NIAID program official prior to
submission of the updated information about the K22 application. NIAID will not
issue the K22 award if the institutional commitment is deemed inadequate.
Applicants who are approved will receive a Notice of Award for the K22 award.

The K22 award is intended to facilitate successful transition to independence.
Consequently, a requirement for activation of the K22 award is successful
completion of this transition. Applicants are encouraged (but not required) to
apply for independent positions at departments and institutions different from
where they conducted their postdoctoral research. It is important for all
applicants, but especially so for applicants who intend to stay at their postdoctoral
institution for the independent phase, to provide a plan by which they will
separate from their postdoctoral advisor and advance to independence. Awardees
are also encouraged to include a plan and timeline for submitting an
independent research grant application in a research area relevant to the
mission of NIAID.

Candidates who are not approved to transition will receive written notification
from NIAID communicating the rationale for the disapproval. This letter
typically will be sent within 60 days of receipt of the updated information
about the K22 application.

Although the financial plans of the NIAID provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Section
VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.